Non Specific Low Back Pain Clinical Trial
— LOMBAFASTOfficial title:
Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP)
The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are: - to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability, - to estimate the cost-utility ratio of the intervention.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 2026 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with subacute or chronic nonspecific low back pain (current episode duration = 6 weeks), resistant to outpatient management, and including patients with radiculopathy as long as low back pain is predominant over pain in the lower extremity. - Patients with less than 30 days off work (declarative) for low back pain in the previous year and involved in a professional activity at the time of inclusion. - Patients manifesting fears and false beliefs and/or dramatization: to be included, the patient will have to answer yes to one of the following two questions: - Are you afraid to move? - Are you afraid you will never get out of it? - Patients eligible for a rehabilitation exercise program - informed and written consent to participate Exclusion Criteria - Age < 18 years, - Insufficient French language proficiency. - Patients having followed a multidisciplinary rehabilitation program for their low back pain in the 3 months preceding inclusion. - Patients who have had lumbar spine surgery within the last 12 months. - Pregnancy in progress. - No affiliation with a health insurance program. |
Country | Name | City | State |
---|---|---|---|
France | Cochin Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | low back pain activity limitation | Variation in the level of low back pain- activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation) | 3 months | |
Secondary | low back pain activity limitation | Variation in the level of low back pain activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation) | 6 and 12 months. | |
Secondary | fears and beliefs about work | Variation in the level of fears and beliefs about work assessed by the work sub score of the self-administered Fear-Avoidance Beliefs Questionnaire (FABQ) (0, no fears and beliefs and 24, maximum fears and beliefs) | 3 months | |
Secondary | fears and beliefs about physical activity | Variation in the level of fears and beliefs about physical activity assessed by the physical activity sub score of the self-administered Fear-Avoidance Beliefs Questionnaire (FABQ) (FABQ), (0, no fears and beliefs and 42, maximum fears and beliefs) | 3 months | |
Secondary | days off work | Number of "days off work" reported by the patient | 3 and 12 months | |
Secondary | low back pain | Variation in the mean intensity of low back pain over the last 48 hours assessed on a self-administered numerical scale (0, no pain and 100,maximum pain) | 3 months | |
Secondary | radicular pain | Change in mean intensity of radicular pain over the last 48 hours assessed on a self-administered numerical scale (0, no pain and 100,maximum pain) | 3 months | |
Secondary | cost-utility ratio | Incremental cost-utility ratio | 12 months |
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